Keratoconus, UnstableEarly Phase 1CXLNCT04731727
Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)
A Early Phase 1 study testing Riboflavin in people with Keratoconus, Unstable, run by Kent Wellish MD.
Trial summary
Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus, Unstable
- What is being tested?
- Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of central or inferior corneal steepening
- Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
- Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
- Fleischer ring
- Vogt's striae
- Decentered corneal apex
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- Munson's sign
- Rizutti's sign
- Apical corneal scarring consistent with Bowman's breaks
- Scissoring of the retinoscopic reflex
- Crab-claw appearance on topography
- Steepest keratometry (Kmax) value > or = 47.20 D
- I-S keratometry difference > 1.5 D on the Orbscan map
- Posterior corneal elevation > 16 microns
- Thinnest corneal point < 485 microns
- Post LASIK/PRK stromal ablation depth < 300 microns or expected keratometry > 47.2 D, or post-PRK/SMILE in keratoconus suspect eyes
- Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of > 25% corneal thickness
- Contact Lens Wearers Only:
- Removal of contact lenses for the required period of time prior to the screening refraction:
- Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid Gas Permeable 2 Weeks per decade of wear
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Who cannot join
- Eyes classified as either normal or atypical normal on the severity grading scheme
- Corneal pachymetry at the screening exam that is < 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or < 300 microns when the hypotonic riboflavin will be used.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
- History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
- Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross linking procedure
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
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- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
- Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Effectiveness of the CCL Vario System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.
Read the detailed description
Corneal thinning conditions, i.e. keratoconus or ectasia, weaken the cornea which then causes the front of the eye to bulge out. This results in distorted vision and could eventually result in the need for a cornea transplant. This study proposes to conclude that saturating the cornea with vitamin B2 (Riboflavin) and then applying 365nm wavelength of Ultra Violet Light will result in the various layers of corneal tissue linking together. This cross linking results in a stronger cornea which is designed to halt the progression of keratoconus or ectasia. This treatment is already being successfully used in Europe.
- Conditions
- Keratoconus, Unstable
- Being tested
- Riboflavin
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDrug
Also called Ultra violet light
Corneal cross linking achieved by combination of Riboflavin and ultraviolet light
| Study group | Role | What they receive |
|---|---|---|
| Cross linking treatment for corneal thinning | Experimental | Cornea will be saturated with Vitamin B2 (Riboflavin) and then treated with 365 nm wavelength ultra violet light. Receives: Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity
Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff
Measured: Baseline and 1 year
Change in Uncorrected Visual Acuity
Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician
Measured: Baseline and 1 year
Occurrence of Adverse Events
Surgeon notes any occurrence of adverse events related to the treatment
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start30 Jun 2021 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconus, UnstableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kent Wellish MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kent Wellish MD, Wellish Vision Institute
- Investigators
- Kent L Wellish, MD, Principal investigator, Wellish Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731727
- Sponsor's protocol ID
- 0000
- Acronym
- CXL
- Status last verified
- May 2021
- First submitted
- 21 Jan 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Unidentifiable patient data and pre- and post-op results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the CCL Vario System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
- ClinicalTrials.gov ID
- NCT04731727
- Acronym / sponsor ID
- CXL / 0000
- Conditions
- Keratoconus, Unstable
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kent Wellish MDUniversity, hospital or other
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.
Detailed description
Corneal thinning conditions, i.e. keratoconus or ectasia, weaken the cornea which then causes the front of the eye to bulge out. This results in distorted vision and could eventually result in the need for a cornea transplant. This study proposes to conclude that saturating the cornea with vitamin B2 (Riboflavin) and then applying 365nm wavelength of Ultra Violet Light will result in the various layers of corneal tissue linking together. This cross linking results in a stronger cornea which is designed to halt the progression of keratoconus or ectasia. This treatment is already being successfully used in Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross linking treatment for corneal thinning | Experimental | Drug: RiboflavinCornea will be saturated with Vitamin B2 (Riboflavin) and then treated with 365 nm wavelength ultra violet light. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Presence of central or inferior corneal steepening
- Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
- Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
- Fleischer ring
- Vogt's striae
Key exclusion criteria (9 listed)
- Eyes classified as either normal or atypical normal on the severity grading scheme
- Corneal pachymetry at the screening exam that is < 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or < 300 microns when the hypotonic riboflavin will be used.
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiboflavinAlso: Ultra violet lightCorneal cross linking achieved by combination of Riboflavin and ultraviolet light | Drug | Cross linking treatment for corneal thinning |
Primary outcome
Change in Best Corrected Visual Acuity
Time frame: Baseline and 1 year
Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff
Change in Uncorrected Visual Acuity
Time frame: Baseline and 1 year
Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician
Occurrence of Adverse Events
Time frame: Through study completion, an average of 1 year
Surgeon notes any occurrence of adverse events related to the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No. Unidentifiable patient data and pre- and post-op results will be shared.
Related trials for Keratoconus, Unstable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kent L Wellish, MD principal investigator
Wellish Vision Institute
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Riboflavin in people with Keratoconus, Unstable, run by Kent Wellish MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tony F Sterrett (702-932-4265, tsterrett@wellish.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best Corrected Visual Acuity (time frame: Baseline and 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.